Medtronic unveils real world data on pulsed field ablation: APHRS meeting in Sydney

MedTech & Diagnostics News: Catheter ablation is a well-established therapy for cardiac arrhythmia in patients with symptomatic atrial fibrillation (AF). At the Asia Pacific Heart Rhythm Society (APHRS) meeting in Sydney, Medtronic announced real-world evidence revealing a high rate of durable lesion formation for its PulseSelect Pulsed Field Ablation (PFA) system for AF.

PFA represents an innovative shift in cardiac electrophysiology. Unlike traditional ablation methods that use radiofrequency or cryothermal energy, PFA relies on pulsed electric fields to induce irreversible electroporation, selectively targeting and destroying arrhythmic tissue. This approach has rapidly gained traction due to its precision and potential for fewer complications.

Data from invasive remapping performed around two months post-ablation using the PulseSelect PFA system showed durable isolation in 98% of pulmonary veins, with 96% of patients having all veins isolated.

“Real-world evidence on chronic lesion formation and durability is critical as use of PFA for the treatment of Afib rapidly increases, making these results impactful and timely for the electrophysiology community,” said Dr Devi Nair, Director of Cardiac Electrophysiology & Research at St. Bernard’s Medical Centre in Arkansas.

“Our research shows that treatment with PulseSelect results in durable lesion formation, which is the cornerstone of successful pulmonary vein isolation and an important addition to previous evidence establishing the safety and effectiveness of this technology.”

The PulseSelect PFA system has seen increased adoption, with over 10,000 procedures performed worldwide. Significant milestones have been achieved in the Asia Pacific region, including regulatory approvals in Australia and China, as well as the system’s launch in Japan following reimbursement approval.

In Australia, Medtronic is also working towards approval of PulseSelect on the Prescribed List (PL), aiming for a November listing.

Professor Hiroshi Tada, President of the Japanese Heart Rhythm Society and Professor of Cardiovascular Medicine at the University of Fukui, Japan, remarked, “PulseSelect is the first PFA catheter to receive reimbursement approval in Japan based on clinical trial results that include Japanese patients. We believe that the future widespread availability of this breakthrough technology under insurance coverage will be of great significance in the history of arrhythmia treatment in Japan.”

Rebecca Seidel, President of Medtronic’s Cardiac Ablations Solutions business, emphasised the significance of the findings, saying “These important results clearly address the durability question and add to the real-world evidence for PulseSelect.

“With expansion in new markets across the Asia Pacific region, physicians around the world are experiencing the benefits of PulseSelect, including proven safety, efficacy, efficiency, and now durability as well. We are thrilled to provide this important tool to physicians for the treatment of patients with atrial fibrillation.”

AF is one of the most common, yet often undertreated, heart rhythm disorders. It typically begins as paroxysmal AF, where episodes are intermittent, but can progress to persistent AF, lasting more than seven days without stopping. As the condition worsens, so does the risk of severe complications such as heart failure, stroke, and even death.

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